Zimmer Biomet Recalls Trauma Guide Wires Due to Packaging Defects
Zimmer Biomet is recalling trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of infection due to sterile barrier failure, which is a risk-of-harm scenario where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling various trauma guide wires, specifically the BEAD TIP GD WIRE 3.0MM X 60CM (catalog number 29402). The recall involves 2,168 units that were distributed worldwide, including the United States, Canada, Australia, Japan, and several other countries.
The recall was initiated due to insufficient packaging design verification and an occurrence rate of complaints for sterile barrier failure that exceeded expected levels. Guide wires packaged in the affected configuration have the potential for sterile barrier breach, which creates a possible risk for infection if the device is used.
These guide wires are intended to be used as guide pins for the insertion of implants, such as cannulated screws and intramedullary nails, and for drilling bone. Consumers and healthcare providers should stop using the affected products and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 2,168
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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